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Serving leading biopharmaceutical companies globally:

Citi
Accenture
Queensland Health
Boehringer Ingelheim
Teva
Chubb
AstraZeneca
Farmers Insurance
McKesson
Chinese Patent Office

Generated: February 19, 2018

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Bupropion hydrobromide - Generic Drug Details

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What are the generic drug sources for bupropion hydrobromide and what is the scope of bupropion hydrobromide patent protection?

Bupropion hydrobromide
is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has forty-nine patent family members in seventeen countries.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for bupropion hydrobromide
Pharmacology for bupropion hydrobromide
Tentative approvals for BUPROPION HYDROBROMIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up174MGTABLET, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up522MGTABLET, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for bupropion hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for bupropion hydrobromide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,553,992 Modified release formulations of a bupropion salt ➤ Sign Up
7,579,380 Modified release formulations of a bupropion salt ➤ Sign Up
9,504,640 Modified release formulations of a bupropion salt ➤ Sign Up
7,645,901 Modified release formulations of a bupropion salt ➤ Sign Up
8,354,453 Bupropion hydrobromide and therapeutic applications ➤ Sign Up
8,932,628 Modified release formulations of a bupropion salt ➤ Sign Up
7,884,136 Modified-release formulations of a bupropion salt ➤ Sign Up
7,563,823 Modified release formulations of a bupropion salt ➤ Sign Up
7,569,611 Modified release formulations of a bupropion salt ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for bupropion hydrobromide

Supplementary Protection Certificates for bupropion hydrobromide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000 Austria ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
C/GB00/019 United Kingdom ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2000 00018 Denmark ➤ Sign Up PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Merck
Colorcon
Healthtrust
Cipla
Moodys
Citi
Federal Trade Commission
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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